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Medium risk Drugs & MedicationsClass II

Siemens Medical Solutions USA, Inc Recall

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

Updated December 29, 2025

Siemens Medical Solutions USA, Inc is recalling Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02. Hazard: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.

Is the Siemens Medical Solutions USA, Inc recalled? Yes. This product was recalled by FDA on December 29, 2025. Details below.

What is recalled

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.

Brands affected

Siemens Medical Solutions USA, Inc
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-1174-2026
Classification
Class II
Recalled
December 29, 2025
Read the official notice

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